Method and apparatus for deflecting a screw-in lead

ABSTRACT

A deflectable stylet system optimized for use in conjunction with a lead of the type having a fixation helix that is screwed into body tissue by rotation of the lead&#39;s connector pin is disclosed. The system includes an attachment that is rotatable and longitudinally slidable with respect to the handle of a deflectable stylet. A lead coupled to the attachment may be moved longitudinally with respect to a stylet to account for slight variances in the lead length. In one embodiment, the attachment couples to the lead via a pushbutton mechanism that can be locked to the lead using one hand. The attachment may be rotated to thereby rotate the lead connector. This allows for retraction and extension of a retractable fixation helix, and for further attachment or detachment of a fixation helix to adjacent tissue. In one embodiment, the attachment may be longitudinally rigidly positioned in predetermined locations with respect to the handle. According to another aspect of the system, a deflection device is coupled to the handle to facilitate deflection of the stylet. In one embodiment, this deflection device may be rotatably and/or slidably activated to accomplish the stylet deflection. The system allows a user to adjust lead length with respect to the stylet length, and to further perform stylet deflection and lead rotation all with one hand.

CROSS REFERENCE TO PRIORITY APPLICATION

This application is a continuation of U.S. patent application Ser. No.10/844,746, filed May 13, 2004 now U.S. Pat. No. 7,396,335; which is adivisional of U.S. patent application Ser. No. 09/659,797, filed Sep.12, 2000 now U.S. Pat. No. 6,805,675; both of which are hereinincorporated by reference in their entirety.

CROSS REFERENCE TO COMMONLY-ASSIGNED PATENTS

Reference is made to commonly-assigned U.S. Pat. No. 6,059,482, filedMay 29, 1998, by Baumann; and to commonly-assigned U.S. Pat. No.6,027,462 issued to Greene et al, which have related subject matter.

BACKGROUND OF THE INVENTION

The present invention relates generally to implantable leads andcatheters and more particularly to mechanisms for deflecting implantableleads and catheters to assist in guiding them through the vascularsystem.

Over the years, quite a number of mechanisms have been disclosed andemployed to deflect catheters and implantable leads. These have takenthe form of deflectable guidewires and deflectable stylets, typicallyoperable from the proximal end of the lead or catheter, whichcontrollably impart a curve to the distal portion of the catheter. Onegroup of devices comprise deflectable stylets or guidewires which employa straight, tubular outer member with a curved inner member, the innerand outer members movable relative to one another. Examples of this typeof deflection mechanism are disclosed in U.S. Pat. No. 4,136,703 issuedto Wittkampf and U.S. Pat. No. 5,728,148 issued to Bostrom et al.Alternatively, deflection devices employing a curved outer member and arelatively straight inner member are also known to the art, as disclosedin U.S. Pat. No. 4,676,249 issued to Arenas and U.S. Pat. No. 5,040,543issued to Badera et al. In devices of both types, the relative positionof the inner member with respect to the outer member determines thedegree to which the curved member (inner or outer) is allowed to displayits preset curvature.

A more commonly employed approach to providing controllable deflectionemploys a generally straight outer member and a tension or push wirelocated within the outer member that, upon advancement or retraction,causes the outer member to bend. Examples of such deflection mechanismscan be found in U.S. Pat. No. 4,815,478 issued to Buchbinder et al., andU.S. Pat. No. 4,940,062 issued to Hampton et al. Particularly in thecontext of deflectable stylets intended for use in conjunction withimplantable medical leads such as pacing and cardioversion leads,steerable stylets employing this third type of deflection mechanism aredisclosed in U.S. Pat. No. 5,662,119 issued to Brennan et al., U.S. Pat.No. 5,170,787 issued to Lindegren, and U.S. Pat. No. 5,327,906 issued toFideler et al, all of which are incorporated herein by reference intheir entireties.

Additional deflectable stylet designs are disclosed in the above-citedBauman and Greene et al applications. In these designs, the handle forthe stylet is provided with a rotatable knob which, like in theabove-cited Fideler patent, is employed to curve and straighten thestylet. This knob is provided with a distally facing recess at itsdistal end. The connector assembly of the lead is located in thisdistally facing recess.

In conjunction with the use of deflectable stylets to implant leadshaving screw-in fixation mechanisms which require rotation of theconnector pin to screw the fixation mechanism into body tissue, it isalso known to employ a spinner ball or clamp to rotate the connectorpin, as described in the Pacesetter Locator Steerable Stylet User Manualfor the Pacesetter Model 4036 Steerable Stylet. The spinner ball, asdescribed, however, does not allow compensation for variations in leadlength or allow for ready adjustment of the position of the styletwithin the lead body. For example, the spinner ball mechanism must bedisconnected from the handle to allow for retraction of the stylet tipwithin the lead to reduce the stiffness at the lead tip.

SUMMARY OF THE INVENTION

The present invention is directed toward providing a deflectable styletsystem particularly optimized for use in conjunction with a lead of thetype having a fixation helix, in which the fixation helix is screwedinto body tissue by rotation of the connector pin of the lead. Inparticular, the invention is intended to provide a deflectable styletsystem that allows for differences in length from lead to lead and alsoprovides an easy mechanism for adjusting the position of the styletwithin the lead body.

The present invention accomplishes the above results by means of anattachment to the stylet handle which includes an affixation device thatmay be connected to the connector pin of the lead. In one embodiment,the affixation device may be a threaded device such as a screw. Inanother embodiment, the affixation device is a pushbutton clevis havingan unlocked position for receiving the lead, and a locked position forrigidly coupling the lead to the attachment.

When the attachment is coupled to the lead, the attachment may berotated to screw the fixation helix into body tissue, configured suchthat the knob and the lead to which it is attached may readily be movedlongitudinally relative to the remainder of the deflectable stylethandle. In a preferred embodiment, the attachment includes a knob with arecess at its distal end for engaging the connector pin of a lead and anelongated tubular extension at its proximal end, slidably inserted intoa corresponding distally facing recess in a deflectable stylet handle.In a more preferred embodiment, the distally facing recess in the stylethandle is formed within the spinner or knob of a deflectable stylethandle generally as disclosed in the above cited Greene et alapplication. The proximally directed extension on the attachment's knoballows for it to be moved longitudinally relative to the stylet handle,in turn allowing for longitudinal movement of the lead relative to thedeflectable stylet.

In one preferred embodiment, the deflectable stylet assembly is alsoprovided with a tubular pin, mounted around the proximal portion of theflexible stylet and mounted in fixed longitudinal relationship with thestylet handle. This tubular pin may engage the interior of theproximally directed tubular extension of the attachment, providing foran additional mechanism to allow longitudinal movement of the attachmentknob relative to the deflectable stylet handle, while retainingappropriate alignment of the attachment knob and stylet handle to allowfor rotation of the attachment knob. In some embodiments, a bushing maybe provided within the attachment to facilitate the free rotation of theattachment around the tubular pin. The attachment may be slip-fit to thetubular pin in a manner that provides for controlled longitudinalrepositioning of the attachment with respect to the stylet assembly. Theattachment may also be adapted to rigidly couple to the tubular pin atpredetermined positions on the pin.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a plan view of a prior art deflectable stylet similar to thatused in conjunction with the present invention.

FIG. 2 is a plan view of the deflectable stylet of FIG. 1 shown insertedinto an implantable cardiac pacing lead.

FIG. 3 is a cut-away view through a partially disassembled controlhandle of one embodiment of the deflectable stylet illustrated in FIG.1.

FIGS. 4 and 5 are cut-away views through the distal portion of thehandle of a deflectable stylet according to the present invention, witha slip-on attachment according to the present invention and a lead withan advanceable fixation helix in place.

FIG. 6 is a cut-away view of another embodiment of the handle assemblyand the attachment.

FIG. 7 is a perspective diagram of the embodiment of the attachmentillustrated in FIG. 6, and further includes the pushbutton clevismechanism.

FIG. 8 is a cross-sectional view of the distal end of the attachmentillustrating the pushbutton in an unlocked position.

FIG. 9 is a cross-sectional view of the distal end of the attachmentillustrating the pushbutton in a locked position.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

FIG. 1 illustrates a plan view of a prior art deflectable stylet,similar to that employed in conjunction with the present invention. Thedeflectable stylet 16 is provided with a control handle assembly 10provided with a handle 12 and a deflection control which takes the formof a spinner or knob 14, mounted rotatably and slidably with respect tothe handle portion 12. The handle 12 is provided with indentations atits proximal end, as is the spinner or knob 14 to assist the physicianin maintaining a grip. Ribbing, knurling or other texturing could ofcourse be substituted. The deflectable stylet 16 exits from a distalrecess 15, within spinner or knob 14. The rotation of spinner or knob 14causes deflection of the distal portion of stylet 16 to a curvedconfiguration as illustrated at 16A.

Deflectable stylet 16 may take the form of any known deflectable styletemploying an outer tubular member and an inner tension wire which, whenit applies tension to the distal tip of deflectable stylet 16, causesthe tip of the stylet to curve. Appropriate designs for the deflectablestylet 16 include those described in the Brennen et al, Lindegren andFideler patents and Bauman and Greene et al. applications discussedabove. Alternatively, deflectable stylet 16 may be replaced by adeflectable guidewire, for example, as disclosed in the above-citedBuchbinder patent, also incorporated herein by reference in itsentirety. In all of these various guidewires and stylets, the basicstructure of the deflectable stylet or guidewire consists of a generallystraight element, and an internal tension wire coupled to the distalportion of this straight element, and arranged such that uponapplication of tension to the internal tension wire, the distal portionof the guidewire or stylet exhibits a curved configuration asillustrated in broken outline at 16A.

FIG. 2 is a plan view of the deflectable stylet of FIG. 1 inserted intoa screw-in cardiac pacing lead 20 of a type not requiring rotation ofthe connector pin relative to the lead body. Cardiac pacing lead 20comprises an elongated insulated lead body 24 carrying an internalconductor and provided with a connector assembly 18 located at itsproximal end, which typically carries a connector pin as is typical ofcardiac pacing leads. For example, the distal portion of the connectorassembly 18 may correspond to the IS-1 connector standard as disclosedin U.S. Pat. No. 4,922,607 issued to Doan et al., also incorporatedherein by reference in its entirety. However, other connectorconfigurations, such as disclosed in U.S. Pat. No. 4,488,561 issued toDoring or U.S. Pat. No. 4,572,605 issued to Hess et al., both alsoincorporated herein by reference in their entireties, may also beemployed. At the distal end of pacing lead 20 is located a fixed helicalelectrode 22, such as that disclosed in U.S. Pat. No. 5,473,812 issuedto Morris et al. and incorporated herein by reference in its entirety,which is screwed into heart tissue in order to stimulate the heart.

As illustrated, the connector assembly 18 of the lead 20 is insertedinto the distal facing opening 15 within spinner or knob 14. The spinneror knob 14 is free to rotate with respect to connector assembly 18.Thus, rotation of the spinner knob does not rotate the connector pin ofthe lead or the lead body itself. However, rotation of the lead bodywith respect to the deflectable stylet is typically required in order toscrew a helical electrode 22 located at the distal end of the lead intoheart tissue. Therefore, an alternative mechanism is needed toaccomplish the affixation of the helical electrode. This mechanism willbe described in detail below.

The above discussion relates to the use of a deflectable stylet inconjunction with an implantable lead. The stylet may further be usedwith any type of steerable catheter, including an ablation catheter.

FIG. 3 is a cut-away view of a partially disassembled handle assembly10, as illustrated in the figures discussed above. The handle 12 isfabricated of two molded plastic parts, joined together essentiallyalong a longitudinal line extending the length of the handle. One of thetwo handle halves 12A is illustrated in conjunction with the knob orspinner 14, showing cross-section and the internal slider 200, notvisible in the previous illustrations. The internal, distally facingrecess 15 in knob 14 is visible in this view, and is sized to be ofsufficient length that it inherently serves as a strain relief to thedeflectable stylet 16, preventing kinking or bending of the stylet atthe point it exits the slider 200. Recess 15 also assists the physicianin repositioning his hand when moving between proximal and distalpositions relative to the handle, in that the portion of the connectorassembly distal to the connector pin is immediately adjacent the distalend of the knob.

The slider 200 generally takes the form of a rod provided with externalthreading 202 which engages internal threading 204 within knob 14. Atthe proximal end of the slider 200 is a collar 206 that engagescorresponding grooves in the molded handle halves, not visible in thisdrawing, to prevent rotation of the slider 200 relative to the handle.Thus, rotation of the knob 14 relative to the handle causes longitudinalmovement, but not rotational movement of the slider 200. The outer tubeof deflectable stylet 16 is mechanically coupled to the slider 200,while the tension wire 208 within the stylet 16 is anchored to thehandle. Thus, on distal movement of the slider 200 relative to thehandle 12A, the outer tube of the stylet is moved with respect to thetension wire 208, causing tension wire 208 to apply tension to the tipof the stylet and deflecting it, in the manner described above in thevarious cited patents pertaining to deflectable stylets. Tension wire208 is anchored to a threaded rod 210 which is adjusted longitudinallyby means of a hex nut 212, which is fixedly mounted in the handle.

As illustrated, the knob 14 and the slider 200 may be longitudinallyslid as a unit without rotation in a distal direction with respect tothe handle. This provides an alternative mechanism for applying tensionto tension wire 208 and deflecting stylet 216. Deflection of the styletby this mechanism is convenient in the case in which the physician wantsto only very briefly and very quickly induce a curve to facilitate entryof the lead into a desired location, for example, into the coronarysinus or for navigating the lead through the vena cava and through thetricuspid valve. Such deflection may be useful for prolapsing the leadin a manner that allows for easy insertion of the lead tip through avalve, for example.

In the embodiment illustrated, the slider is provided with an internalbore 214 which may receive the connector pin of an implantable lead. Inthis case, the bore 214 should be of larger diameter than the connectorpin, so that the lead may be rotated with respect to the stylet 216.Alternatively, the bore 214 may be omitted, with the connector pinsimply lying adjacent the distal end of the slider 200.

FIG. 4 illustrates a cut-away view through the distal portion of adeflectable stylet handle in conjunction with an attachment according tothe invention, to which the connector pin of a lead of the type having afixation helix is attached. As illustrated, the deflectable styletcontrol handle corresponds generally to that described in the abovecited Greene et al patent and as illustrated in FIGS. 1-3. Handle 12A,knob or spinner 14, deflectable stylet 16 and tension wire 208correspond to identically numbered components as illustrated in FIGS.1-3 and discussed above. Slider 200A of this embodiment correspondsgenerally to slider 200. Operation of the deflectable stylet handle inand of itself is identical to that described above in conjunction withFIGS. 1-3. It may be noted that the embodiment of FIG. 4 shows extendingscrew threads 202A being cut away in portions. This allows ethyleneoxide gas to more easily penetrate the threads during the sterilizationprocess.

Also illustrated is an attachment 304 according to the present inventionmounted to the stylet handle. Attachment 304 includes a generallycylindrical knob 316 from which a generally tubular member 314 extendsproximally. Tubular member 314 is mounted with a slip-fit to tubular pin300 within the distal facing recess 15 of knob or spinner 14. Theattachment 304 may be slid longitudinally within that recess, and mayalso be rotated with respect to tubular pin 300.

At the distal end of the attachment 304 is a distally facing bore inwhich the connector pin 310 of a pacing lead 312 is inserted and isretained by screw 308. Lead 312 may be of the type having a fixationhelix, wherein the fixation helix is advanced by rotation of thisconnector pin 310. Rotation of the fixation helix is discussed furtherbelow.

Tubular pin 300 is mounted within recess 214A, in the distal end ofslider 200A, and is retained therein frictionally, by adhesive orotherwise. Plug 306 is mounted to the proximal end of the tubular member314. Located within the proximally extending tubular member 314 ofattachment 304 is a bushing 302, which surrounds a tubular pin 300 thatis in turn mounted around deflectable stylet 16. Bushing 302 isadhesively or otherwise bonded to the interior of the tubular member314, and is free to rotate with respect to tubular pin 300. Bushing 302provides the friction fit between attachment 304 and tubular pin 300 toallow attachment 304 to be slid in a controlled manner along tubular pin300. Pin 300 thereby allows for an increase in the range of availablecontrolled longitudinal movement of attachment 304 relative to adeflectable stylet handle.

The current invention provides an efficient mechanism for adjusting theposition of the stylet 16 within the body of lead in a controlled mannerusing only a single hand. In contrast, the prior art mechanismsdiscussed above for adjusting lead position with respect to the styletrequire the detachment of the lead from the handle before longitudinalmovement of the lead body is possible. In most cases, these prior artmechanisms require two hands to operate, and do not allow for controlledmovement of the lead body with respect to the handle.

FIG. 5 is a cut-away view of components that are similar to thoseillustrated in FIG. 4, with all identically numbered componentscorrespond to those in FIG. 4. In this view, attachment 304 is shownadvanced distally on tubular pin 300 out of the recess in knob orspinner 14, for a distance “A” which may be, for example, about an inch.Because tubular pin 300 extends distally to the end of knob or spinner14, it is possible to move the attachment 304 to a point wherein onlythe proximal most portion of the attachment is located within the recesswithin spinner or knob 14, while retaining the correct alignment of theattachment with respect to the deflectable guidewire and deflectableguidewire handle.

The current invention may be used to adjust a stylet length to that of aparticular lead. The stylet length may be adjusted by a length “A” asshown by extended position 320 of FIG. 5. For example, in someinstances, lead lengths may vary by several inches. For leads that arelonger, the attachment may be positioned in its most retracted positionso that the tip of the stylet is positioned at the end of the lead. Forleads that are shorter, the attachment 304 may be positioned at a moreextended location within the recess of spinner or knob 14. Theattachment therefore allows the flexibility to manufacture longer leador catheter bodies that may be trimmed and reworked if a defect in theconnector is experienced. This reduces overall manufacturing costs,since fewer leads or catheters must be disposed of because ofmanufacturing defects.

In addition to providing an efficient mechanism for adjusting styletlength, the current invention further provides a mechanism for rotatinga helical electrode. As stated previously, the connector pin 310 of apacing lead 312 is inserted and retained by screw 308 of attachment 304.Therefore, rotation of attachment 304 will result in rotation of theconnecting pin and any interconnected helical electrode that ispositioned at the distal end of the lead. This allows the helicalelectrode to be attached to, or detached from, adjacent tissue. It maybe noted that the current invention is suitable for use with bothretractable and fixed-screw helical electrodes, and is particularlyuseful when retractable helical electrodes are used.

FIG. 6 is a cut-away view of another embodiment of handle assembly 10and attachment 304, as illustrated in the figures discussed above. Inthis Figure, all components corresponding to those in FIGS. 4 and 5 arelabeled with the same reference numbers as used in the previous FIGS. 4and 5 for ease of reference. As in the embodiments discussed above, thisembodiment includes a handle fabricated of two molded plastic parts,joined together essentially along a longitudinal line extending thelength of the handle. One of the two handle halves shown as 12A isillustrated in conjunction with the knob or spinner 14, shown incross-section, and the internal slider 200, not visible in the previousillustrations.

The embodiment of the handle shown in FIG. 6 is very similar to thatshown in previous FIGS. 4 and 5, with a few exceptions. For example,tension wire 208 is anchored to wire anchor 330, and is notlongitudinally adjustable as is the tension wire shown in FIGS. 4 and 5.Instead, tension wire 208 is adhesively bonded or potted into anchor 330by epoxy for superior tensile strength.

FIG. 6 further illustrates another embodiment of the attachment. As inthe embodiments discussed above, the attachment of this embodiment isfabricated of two molded plastic parts, joined together essentiallyalong a longitudinal line extending the length of the handle, with thehalf of the attachment 304 a being shown in FIG. 6. As with theattachment discussed above in reference to FIG. 5, this attachmentincludes a generally cylindrical knob 316 from which a generally tubularmember 314 extends proximally. Tubular member 314 is rotatably mountedto a tubular pin 334 within the distal facing recess 15 of knob orspinner 14 and is also slidable longitudinally within that recess. Inthis embodiment, tubular member 314 includes a ball-detent couplingmechanism (not shown in FIG. 6) to be described further below. Thiscoupling mechanism is adapted to be rigidly positioned longitudinallywith respect to any of the notches 336 included within pin 334. Thus,attachment 304 a may be rigidly re-positioned longitudinally atpredetermined intervals along at least a predetermined portion of thelength of pin 334 while rotating freely in the notches.

This embodiment may further include an elastomeric ring-like structuresuch as O-ring 360 shown positioned in recess 361. The O-ring allows theattachment to be longitudinally re-positioned at an infinite number ofpositions using a friction fit with pin 334. O-ring may be used inaddition to, or instead of, the ball-detent coupling mechanism discussedbelow.

In the embodiment of FIG. 6, attachment 304 a further includes a leadattachment mechanism that uses a pushbutton clevis to fix the lead pinto attachment 304 a. FIGS. 8 and 9 each illustrate a cross-section ofthis pushbutton 340 that resides within a recess 338 a and couples theconnector pin 310 of a pacing lead 312 to the attachment. The pushbuttonclevis is discussed further below. This is an alternative couplingmechanism to screw 308 of FIG. 5. The embodiment of FIGS. 8 and 9provides the advantage of requiring only a single, one-handed motion toengage and disengage the coupling mechanism as compared to the screw 308of FIG. 5.

FIG. 7 is a perspective diagram of first and second halves 304 a and 304b, respectively, of the attachment of the embodiment of FIG. 6,including pushbutton clevis 340. Pushbutton 340 is adapted to slidablyengage within a recess 338 b of attachment half 304 b, and to furtherengage in similar recess 338 a (shown in FIG. 6) of attachment half 304a when the attachment halves are coupled together as shown by the dashedlines of FIG. 7. The pushbutton is prevented from falling out ofrecesses 338 b by a locking travel limit pin 347 shown protrudingperpendicularly from a proximal face of the pushbutton. When insertedwithin the recess, the pushbutton generally resides in either a firstloose position, or a second locked position that will be discussed inmore detail below.

Each of the attachment halves further includes a cut-away area 342 a and342 b on the distal face of cylindrical knob 316 of attachment halves304 a and 304 b, respectively. This cut-away area accommodates thepositioning of a lead connector pin 310 of lead 312. When the pushbuttonis in the loose position, the connector pin 310 of lead 312 may beeasily inserted into this cut-away area. Once the lead connector is sopositioned, the pushbutton may be snapped into the locked position suchthat pushbutton 340 traps connector pin 310 within one end of aperture345. This fixes the implantable lead 312 in a rigid position withrespect to the attachment. Rotation of the cylindrical knob 316 will nowrotate the entire lead body, allowing for easy fixation of a helicalscrew that may be carried at the distal end of the lead body withinadjacent tissue. This pushbutton mechanism is further discussed below.

FIG. 7 further shows the coupling mechanism 348 that is provided tocouple to notches 336 included within pin 334. In one embodiment, thiscoupling mechanism is a protrusion 348 that may be included on one orboth of the attachment halves 304 a and 304 b. This protrusion may be,for example, one or more stainless steel balls embedded within arespective wall of one or both of attachment halves 304 a and 304 b.This protrusion is adapted to fit within any of notches 336 to allow theattachment to be selectably positioned at regular intervals along pin334. Such a positioning mechanism allows for more controlled positioningof the lead body with respect to the stylet.

In another embodiment, attachment halves 304 a and 304 b do not includea coupling mechanism such as protrusion 348. Instead, the elastomericO-ring 360 is positioned in recess 361 between attachment halves 304 aand 304 b to fit over tubular pin 334 as shown in FIG. 6. The O-ringallows the attachment to be longitudinally re-positioned at an infinitenumber of positions using a friction fit. Because the O-ring fitsloosely within recess 361, the attachment is able to rotate freely aboutO-ring 360, and therefore also rotate freely around pin 334. In yetanother embodiment, both the O-ring 360 and protrusion 348 may beemployed in conjunction with tubular pin 334 to provide bothlongitudinally rigid positioning at discrete intervals, and slipped-fitpositioning at locations intermediate the discrete intervals.

FIG. 8 is a cross-sectional view of the distal end of the attachmentwith halves 304 a and 304 b coupled together, and further illustratingthe pushbutton 340 in a loose position. In this position, a connectorpin 310 of lead 312 (not shown in this view) may be easily inserted intothe aperture formed by cut-away areas 342 a and 342 b. A connector pin310 so inserted is not in intimate contact with aperture 345, and may beeasily rotated with respect to the attachment.

FIG. 9 is a cross-sectional view of the distal end of the attachmenthalves 304 a and 304 b coupled together, and further illustrating thepushbutton 340 in a locked position. A connector pin 310 of lead 312(not shown in this view) inserted into the recesses 338 a and 338 b willbe intimate contact with recess 345 so that rotation of the attachmentrotates the connector pin 310. When using a lead having a fixed-screwhelical electrode, this rotation will rotate the lead body and thehelical electrode. When using a lead employing a retractable helicalelectrode, this rotation will extend or retract the electrode so thehelix may be attached to, or detached from, respectively, adjacenttissue.

The attachment of the current invention provides a mechanism for easilymanipulating a lead assembly with a single hand. Only a single hand isneeded to grasp handle assembly 10, to further rotate or slide knob 14to deflect a distal tip of a guidewire inserted within a lead, and torotate attachment 304 to facilitate rotation of the entire lead.Furthermore, using the embodiment of FIG. 7, affixing the lead toattachment 304 may be accomplished with a quick snap of pushbutton 340that may also be performed with the same hand. This easy, one-handedcontrol system of the current invention thus frees up one hand of thephysician for other tasks.

Modifications to the embodiments discussed above are permissible withinthe scope of the invention, and the possibility of such modificationshould be understood in conjunction with the claims that follow. Forexample, in some embodiments, pin 300 might be eliminated, however, insuch embodiments, the available range of longitudinal movement of theattachment 304 relative to the deflectable stylet handle would bereduced somewhat. Similarly, in some alternative embodiments, the recesswithin the knob or spinner 14 might be reduced or eliminated entirely,with the attachment retained in alignment with and mounted to thedeflectable stylet handle only by means of tubular pin 300. Similarly,as noted above, other mechanisms for inducing curvature of thedeflectable stylet might be substituted for that employed in the handleas illustrated. For example, a knob or handle might be attached directlyto the slider 200A, and employed to directly move the sliderlongitudinally, eliminating the necessity for a rotatable knob. As such,the embodiment illustrated above should be considered as exemplary,rather than limiting, when interpreted in conjunction with the claimswhich follow.

1. A system for manipulating a lead in conjunction with a deflectableguidewire or stylet, the guidewire or stylet being deflectable by meansof a slider attached thereto, the slider being attached to a handle ofthe system, and the system further comprising: an attachment beingslidably and rotatably mounted around the deflectable guidewire orstylet, distal to the slider, and comprising means for retaining aproximal end of the lead in which the guidewire or stylet is inserted,such that the attachment and the retained proximal end of the lead canbe rotated and slid longitudinally relative to the slider; and whereinthe handle comprises a distally facing recess, and a portion of theattachment that is mounted around the guidewire or stylet extends withinthe distally facing recess.
 2. The system of claim 1, wherein the handlefurther comprises a knob coupled to the slider, the knob being rotatableto advance or retract the slider in a longitudinal direction and therebycause the deflection of the deflectable guidewire or stylet; and thedistal facing recess is formed in the knob.
 3. The system of claim 1,wherein the means for retaining the proximal end of the lead includes apushbutton capable of being in a first unlocked position, to receive theproximal end, and in a second locked position, to rigidly couple withthe proximal end.
 4. The system of claim 1, wherein the means forretaining the proximal end of the lead includes a threaded fasteningdevice.
 5. The system of claim 1, further comprising a member adapted toallow the attachment to be rigidly positioned longitudinally atselectable locations relative to the guidewire or stylet and the handle.6. A system for manipulating a lead in conjunction with a deflectableguidewire or stylet, the guidewire or stylet being deflectable by meansof a slider attached thereto, the slider being attached to a handle ofthe system, and the system further comprising: a pin member mountedaround the guidewire or stylet distal to the slider; and an attachmentbeing slidably and rotatably mounted around the pin member, distal tothe slider, and comprising means for retaining a proximal end of thelead in which the guidewire or stylet is inserted, such that theattachment and the retained proximal end of the lead can be rotated andslid longitudinally relative to the slider.
 7. The system of claim 6,wherein the handle comprises a distally facing recess in which the pinmember and a portion of the attachment that is mounted around the pinmember extend.
 8. The system of claim 7, wherein the handle furthercomprises a knob coupled to the slider, the knob being rotatable toadvance or retract the slider in a longitudinal direction and therebycause deflection of the deflectable guidewire or stylet; and thedistally facing recess is formed in the knob.
 9. The system of claim 6,wherein the means for retaining the proximal end of the lead includes apushbutton to receive the proximal end, when in an unlocked position,and to rigidly couple with the proximal end, when in a locked position.10. The system of claim 6, wherein the pin member includes notchesinterfacing with the attachment thereby allowing the attachment to berigidly positioned longitudinally at selectable locations along pinmember.
 11. The system of claim 6, further comprising an O-ringpositioned to provide a friction fit between the attachment and the pin.